Podium Session

PD09-10: Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): long-term outcomes from JAVELIN Bladder 100 in subgroups defined by response to 1L chemotherapy

Podium Presenter(s)

• 

  Shilpa Gupta, MD

  Professor of Medicine at Cleveland Clinic Lerner College of Medicine at CWRU
  Cleveland Clinic Foundation

Introduction: In the phase 3 JAVELIN Bladder 100 trial (NCT02603432), avelumab 1L maintenance + best supportive care (BSC) significantly prolonged overall survival (OS) vs BSC alone in patients with advanced UC that had not progressed with 1L platinum-based chemotherapy. We report exploratory analyses in subgroups defined by response to 1L chemotherapy (complete response [CR], partial response [PR], or stable disease [SD]) after =2 years of follow-up.

Methods: Eligible patients had unresectable locally advanced or metastatic UC without progression with 4-6 cycles of 1L gemcitabine + cisplatin or carboplatin. Patients were randomized 1:1 to receive avelumab + BSC (n=350) or BSC alone (n=350), stratified by best response to 1L chemotherapy (CR/PR vs SD) and visceral vs nonvisceral disease at start of 1L chemotherapy.

Results: At data cutoff (June 4, 2021), median follow-up in both arms was =38 months. OS and PFS were longer in the avelumab + BSC vs BSC alone arm in all subgroups (Table). Median duration of study treatment and incidence of grade =3 treatment-emergent adverse events (TEAEs) in subgroups are shown in the Table. In the avelumab + BSC vs BSC alone arm, respectively, subsequent second-line anticancer drug therapy was received by: CR subgroup, 50.0% vs 74.2%; PR subgroup, 58.3% vs 71.8%; and SD subgroup, 46.4% vs 70.4%.

Conclusions: Long-term follow-up from JAVELIN Bladder 100 continues to show prolonged OS and PFS with avelumab + BSC vs BSC alone irrespective of response (CR, PR, or SD) to 1L chemotherapy and despite a higher proportion of patients in the BSC alone arm receiving subsequent therapy. Long-term safety was consistent across subgroups. These findings further support avelumab 1L maintenance as standard of care for all patients with advanced UC that has not progressed with 1L platinum-based chemotherapy. © 2022 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2022 ASCO Annual Meeting. All rights reserved. SOURCE OF

Funding: This trial was sponsored by Pfizer as part of an alliance between Pfizer and the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945). Medical writing support was provided by Jamie Ratcliffe of ClinicalThinking and was funded by Pfizer and the healthcare business of Merck KGaA, Darmstadt, Germany.